Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation

Figures & data

Table 1 Classification Of Exacerbation Severity In The RESTORE Study Based On Health Care Utilization²⁶

Exacerbation Severity	Level Of Health Care Utilization
Mild	Patient has an increased need for medication (bronchodilators), which he/she can manage in own normal environment
Moderate	Patient has increased need for medication (antibiotics and/or systemic corticosteroids) and feels the need to seek additional medical assistance
Severe	Patient/caregiver recognizes obvious and/or rapid deterioration in condition, requiring hospitalization or an emergency department visit

Table 2 Demographic And Baseline Characteristics Of Patients (ITT population)

	Moderate COPD^a (N=254)		Severe COPD^b (N=191)		All RESTORE Patients^c (N=445)
	Erdosteine	Placebo	Erdosteine	Placebo	Erdosteine	Placebo
Patients, n	126	128	89	102	215	230
Age, years	64.8 (7.6)	66.1 (7.3)	62.9 (8.9)	63.1 (8.8)	63.8 (8.3)	64.1 (8.2)
Male, %	65.9	72.7	74.5	73.9	71.8	74.6
BMI, kg/m^Citation2	27.6 (5.0)	28.2 (5.6)	27.0 (4.8)	27.8 (5.1)	27.2 (5.3)	28.0 (5.4)
Smoking status, %
Current smoker	31.7	28.9	25.8	27.5	27.1	28.0
Ex-smoker	68.3	71.1	74.2	72.5	72.9	72.0
ICS,^d n (%)	88 (69.8)	91 (71.1)	80 (89.9)*	94 (92.2)*	165 (75.8)	173 (75.2)
FEV1, L	1.61 (0.35)	1.68 (0.42)	1.26 (0.39)	1.23 (0.43)	1.43 (0.40)	1.46 (0.47)
FEV1, % predicted	59.88 (6.3)	61.08 (6.8)	47.21 (10.83)	46.72 (11.69)	51.45 (12.82)	54.38 (13.33)
FVC, L	2.82 (0.66)	2.89 (0.72)	2.59 (0.99)*	2.54 (0.97)*	2.74 (0.93)	2.74 (0.94)
Post-BD FEV1/FVC, ratio %	58.76 (8.8)	58.00 (8.1)	51.92 (9.88)*	50.81 (10.03)*	54.01 (11.3)	53.26 (10.8)

Notes: Data are presented as mean (standard deviation) unless indicated otherwise. ^aModerate COPD group determined post hoc based on GOLD 2011 spirometry criteria (FEV1 50‒79% predicted); ^bSevere COPD group determined post hoc based on GOLD 2011 spirometry criteria (FEV1 30%‒49% predicted); ^cData from Dal Negro et al;^23dICS alone or combined with adrenergic agents. *P<0.05 versus moderate COPD group. (Categorical variables have been compared as continuous depending on the distribution: if normal with t-tested for independent samples, if not normal with comparisons between treatment groups used the Mann–Whitney U-test). All comparisons between the erdosteine and placebo groups were non-significant.

Abbreviations: BD, bronchodilator; BMI, body mass index; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; ITT, intention-to-treat; NS, not significant for comparison between treatment groups.

Figure 1 Patient disposition in RESTORE study.

Figure 2 Exacerbation rate according to COPD severity subgroup and for all patients in the RESTORE study.

Table 3 Exacerbation Duration (In days) By Exacerbation Severity (Mild Or Moderate-To-severe), COPD Severity And Treatment Group

	Erdosteine	Placebo	%Change	P-value
Moderate COPD patients (N=254)
All exacerbations	9.1 (7.4)	12.3 (9.6)	−26.0 (5.6)	0.022
Mild exacerbations	7.7 (4.9)	9.8 (8.0)	−21.4 (5.0)	0.037
Moderate-to-severe exacerbations	10.5 (8.5)	13.7 (10.4)	−23.4 (4.8)	0.040
Severe COPD patients (N=191)
All exacerbations	10.9 (7.5)	12.8 (9.9)	−14.8 (4.7)	0.093
Mild exacerbations	8.7 (5.8)	10.4 (7.8)	−16.3 (4.8)	0.131
Moderate-to-severe exacerbations	13.9 (9.8)	15.0 (11.2)	−7.3 (3.4)	0.241
All RESTORE patients (N=445)
All exacerbations	9.5 (7.2)	12.6 (9.7)	−24.6 (5.3)	0.023
Mild exacerbations	8.4 (5.2)	10.4 (8.2)	−19.2 (4.9)	0.039
Moderate-to-severe exacerbations	11.1 (8.9)	14.1 (10.8)	−21.3 (5.2)	0.041

Note: Data are presented as mean (standard deviation) in days.

Figure 3 Exacerbation-free time (mean days) in patients with moderate COPD and for all patients in the RESTORE study.

Figure 4 Exacerbation rate by blood eosinophil count (<150 cells/μL and ≥150 cells/μL) for patients with moderate COPD by treatment group.

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